Providing Tools for Effective Care and Treatment of Anxiety Disorders

NCT ID: NCT02605668

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 726 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-12
• Study Completion Date: 2019-07-24

Brief Summary

PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.

It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, the investigators want to investigate the effect of extinction learning in an "intensified" psychological intervention on treatment outcome in adults and children with anxiety disorders.

The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.

Detailed Description

Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an "intensified" exposure-based treatment, improves outcomes. In a multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.

Conditions

Panic Disorder; Agoraphobia; Specific Phobias; Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensified Psychological Intervention

Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning

Group Type: EXPERIMENTAL

Intensified psychological intervention

Intervention Type: BEHAVIORAL

12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)

Treatment As Usual

Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning

Group Type: ACTIVE_COMPARATOR

Standard intervention

Intervention Type: BEHAVIORAL

12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)

Interventions

Intensified psychological intervention

12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)

Intervention Type: BEHAVIORAL

Standard intervention

12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 15 - 70 years
• one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
• HAMA - Score > 18
• CGI - Score > 3
• Can attend therapy regularly (with or without support)
• Informed Consent

Exclusion Criteria

• Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
• Current suicidal tendency
• DSM-5 Bipolar Disorder
• DSM-5 Psychotic Disorder
• DSM-5 Borderline Personality Disorder
• Current treatment of other mental disorder (drugs, psychotherapy)
• Current Alcohol, Benzodiazepine or other Substance Use Disorders
• Severe medical illness/condition (every serious physical illness, including cardiovascular, kidney, endocrinological and neurological conditions, Hepatitis or other clinical findings that suggest a severe illness and may affect participation in the study)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Wuerzburg

OTHER

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: collaborator

Universität Münster

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Ulrich Wittchen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy

Dresden, Saxony, Germany

Countries

Germany

References

Heinig I, Pittig A, Richter J, Hummel K, Alt I, Dickhover K, Gamer J, Hollandt M, Koelkebeck K, Maenz A, Tennie S, Totzeck C, Yang Y, Arolt V, Deckert J, Domschke K, Fydrich T, Hamm A, Hoyer J, Kircher T, Lueken U, Margraf J, Neudeck P, Pauli P, Rief W, Schneider S, Straube B, Strohle A, Wittchen HU. Optimizing exposure-based CBT for anxiety disorders via enhanced extinction: Design and methods of a multicentre randomized clinical trial. Int J Methods Psychiatr Res. 2017 Jun;26(2):e1560. doi: 10.1002/mpr.1560. Epub 2017 Mar 21.

Reference Type: BACKGROUND

PMID: 28322476 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DRKS00008743

Identifier Type: REGISTRY

Identifier Source: secondary_id

01EE1402A

Identifier Type: -

Identifier Source: org_study_id